Action at the Capitol to Improve Access to Biologic Samples by Biosimilar Developers?

The Trump Administration has indicated a desire to streamline marketplace rules to improve the efficiency of the Food and Drug Administration (FDA) and to enhance manufacturers’ access to the marketplace. “President Trump issued an executive order to this effect,” said Mary Jo Carden, RPh, JD, Vice President of Legislative and Pharmacy Affairs, Academy of Managed Care Pharmacy (AMCP). But “what that means is still a question.”

Efforts are underway to clear away a roadblock to manufacturers who are trying to bring a competitive biosimilar to the marketplace. Step 1 in the process of building a biosimilar, before a drugmaker can begin to develop and characterize a biosimilar version of an originator, is to obtain samples of the licensed biologic. This is not as simple as it sounds. Those companies producing the originator may be unwilling to provide samples or charge extremely high rates for the use of their product, as a way of stalling competition. Some manufacturers have used REMS and internal distribution restrictions as a reason not to sell to biosimilar drug developers.

Reginia Grayson Benjamin, JD, Director of Legislative Affairs for the Academy, said that two separate initiatives are being developed in Congress to address this problem. First introduced in June 2016 by Senator Patrick Leahy (D-VT) (S. 3056), the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, will need to be reintroduced in 2017. It is an effort to assist competition in the biologics market, by facilitating entry of biosimilars (and small-molecule generics). The CREATES Act,” according to Ms. Grayson Benjamin, “seeks a legal solution to the sample access problem, by creating a right to a civil cause of action for failure to provide sufficient quantities of a covered product.”

Second is the Fair Access to Safe and Timely Generics (FAST) Act, which may be reintroduced into the House of Representatives. It was first brought to Congress in June 2015 by Representative Steve Stivers (R-OH) as H.R. 2841, and did not make it out of the Subcommittee on Health. Ms. Grayson pointed out that it is not a companion to the CREATES Act, but it “would create a regulatory solution,” she said.

However, these proposals, which have not yet been formally debated or sent to committee, and other health care–related bills that have been introduced, have received little consideration because of actions surrounding and the ultimate vote to reject the American Health Care Act.

UPDATE: On April 6, H.R. 2051 was introduced in the House by Representative David B. McKinley (R-WV). This is a reboot of the FAST Act, and has been referred to the Referred to the House Committee on Energy and Commerce.